Does the Stapled Transanal Rectal Resection (STARR Procedure) Has an Effect on Anal Compliance ? (Compli-STARR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02052063|
Recruitment Status : Recruiting
First Posted : January 31, 2014
Last Update Posted : December 7, 2016
The stapled transanal rectal resection (STARR) has recently been recommended for patients with obstructed defecation syndrome (ODS) caused by rectocele and rectal wall intussusception.
The aim of STARR is to correct the mechanical outlet obstruction using a stapler device for endorectal resection of the distal rectum.
This technique significantly improves constipation. However, there are several reports of new-onset faecal incontinence after STARR and urgency has been identified as the major side-effect of this procedure.
Although this technique has become an important surgical option in the treatment of obstructive defaecation syndrome, its impact on continence can be problematic and objective data about parameters that predict its result are not yet available One study evaluated the anal function after surgery in 30 patients. In this study, urgency or incontinence was complained by 26% of patients. No sonographically demonstrable sphincter fragmentations were noticed in the endoanal exam performed at the follow-up.
No significant difference was observed in anorectal manometry. Even if data are not statistically significant, resting and squeezing pressures are lower in those patients not satisfied.
Currently, anal canal pressure measurements using ano-rectal manometry are the most common means of assessment of sphincter function. Some studies have been looking at the concept of distending sphincter regions as a better measure of its performance.
The functional lumen imaging probe (FLIP) is a novel technique which has the ability to provide real-time images of the function of human gastrointestinal sphincter during distension. This distensibility technique provides an important new way of studying the anal canal and hence may have a role in testing sphincter competence in patients with disorders after STARR procedure.
Twenty-eight patients will be enrolled in this study over a period of 36 months.
Preoperative assessment will include
- clinical examination
- the Wexner Incontinence Score and the Faecal Incontinence Quality-of-Life Index (FIQL) to rate anal incontinence
- video defecography, anorectal manometry, anal ultrasound (AUS) and measure of anal sphincter distensibility using endoFLIP Follow-up evaluation will scheduled for 3 months after surgery, and will include symptom evaluation (using the same standard questionnaires for incontinence), clinical examination and investigation using anal ultrasound and endoFLIP.
If we demonstrate that this surgical technique can cause anal lesions with decreased sphincter competence, this may lead to a modification of the surgical technique especially in patients at risk of developing postoperative anal incontinence.
|Condition or disease||Intervention/treatment||Phase|
|Rectocele Intussusception Surgery Sphincter Ani Incontinence||Device: stapled transanal rectal resection Device: Anal compliance measure with Endoflip system||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Does the Stapled Transanal Rectal Resection (STARR Procedure) Has an Effect on Anal Compliance ?|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
Patient who undergone stapled transanal rectal resection for rectocele. Anal compliance will be evaluated before and starting the surgery using endoflip system
Device: stapled transanal rectal resection
transanal rectal resection using staple will be done for rectocele
Other Name: transanal rectal resection using staple
Device: Anal compliance measure with Endoflip system
Anal compliance will be measured using Endoflip system
- Comparison of anal sphincter distensibility [ Time Frame: Month 3 ]
Comparison of anal sphincter distensibility before and 3 months after surgery with cross-sectional area and intra-balloon pressure.
The device used is Endoflip system
- Comparison of Faecal Incontinence Quality-of-Life Index (FIQL) before and 3 months after surgery [ Time Frame: Month 3 ]Comparison of Faecal Incontinence Quality-of-Life Index (FIQL) before and 3 months after surgery
- Comparison of radiological data (Anal ultrasound) [ Time Frame: Month 3 ]Comparison of radiological data (Anal ultrasound) before and 3 months after surgery Endo-rectal Brüel and Kjaer echographic probe will be used to compare radiological data (conventional endo-rectal echography)
- Comparison of Cleveland Clinic Incontinence score (CCIS) before and 3 months after surgery [ Time Frame: Month 3 ]Comparison between Cleveland Clinic Incontinence score (CCIS)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02052063
|Contact: Valérie BRIDOUX, MD||+3323288 ext email@example.com|
|Contact: Julien BLOT||+3323288 ext firstname.lastname@example.org|
|Rouen, France, 76031|
|Contact: Valérie BRIDOUX, MD +3323288 ext 8142 email@example.com|
|Principal Investigator: Valérie BRIDOUX, MD|
|Principal Investigator:||Valérie BRIDOUX, MD||UH Rouen|